Articles by Stephen Colgan - Pharmaceutical Technology

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Articles by Stephen Colgan

Using Quality by Design to Develop Robust Chromatographic Methods

Quality-by-design principles can be used to understand chromatographic measurement system variability.
Sep 2, 2014

The quality-by-design principles used to control process variability are equally important to measurement systems because process variability includes contributions from measurement system variability. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.

Pharmaceutical Stability: Scientific and Regulatory Considerations for Global Drug Development and Commercialization

A two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC.
Nov 3, 2012

A two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC.

AAPS Workshop Summary

A two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC. This article summarizes some of the topics presented at the AAPS workshop on various scientific aspects affecting pharmaceutical stability. A full summary can be read online at www.PharmTech.com/AAPSstability. A follow-up AAPS workshop on pharmaceutical stability is being planned for 2013.
Nov 2, 2012

A two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC.

Early Development GMPs for Stability (Part IV)

IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development, with a focus on stability.
Sep 2, 2012

IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development, with a focus on stability.

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